Products, Contact Lens Care, Rigid Gas Permeable

Device Code: 4352

Product Code(s): MRC

Device Classification Information

Device Type ID	4352
Device Name	Products, Contact Lens Care, Rigid Gas Permeable
Regulation Description	Rigid Gas Permeable Contact Lens Care Products.
Regulation Medical Specialty	Ophthalmic
Review Panel	Ophthalmic
Premarket Review	Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Contact Lenses And Retinal Devices Branch (CLRD)
Submission Type	510(k)
CFR Regulation Number	886.5918 [🔎]
FDA Device Classification	Class 2 Medical Device
Product Code	MRC
GMP Exempt	No
Summary MR	Eligible
Implanted Device	No
Life Support Device	No
Third Party Review	Eligible For Accredited Persons Program

Recognized Standards

10-60 ISO 11981 Second Edition 2009-07-01
Ophthalmic Optics - Contact Lenses And Contact Lens Care Products - Determination Of Physical Compatibility Of Contact Lens Care Products With Contact Lenses
10-67 ISO 11986 Second Edition 2010-11-01
Ophthalmic Optics - Contact Lenses And Contact Lens Care Products - Guidelines For Determination Of Preservation Uptake And Release
10-77 ISO 9394 Third Edition 2012-10-01
Ophthalmic Optics - Contact Lenses And Contact Lens Care Products - Determination Of Biocompatibility By Ocular Study With Rabbit Eyes
10-85 ISO 11980 Third Edition 2012-11-15 Corrected Version 2012-12-01
Ophthalmic Optics - Contact Lenses And Contact Lens Care Products - Guidance For Clinical Investigations
10-86 ISO 14729 First Edition 2001-04-15
Ophthalmic Optics - Contact Lens Care Products - Microbiological Requirements And Test Methods For Products And Regimens For Hygienic Management Of Contact Lenses [Including: Amendment 1 (2010]
10-99 ISO 4311 First Edition 1979-06-01
Anionic And Non-ionic Surface Active Agents - Determination Of Critical Micellization Concentration - Method By Measuring Surface Tension With A Plate, Stirrup, Or Ring
10-100 ISO 18259 First Edition 2014-10-01
Ophthalmic Optics - Contact Lens Care Products - Method To Assess Contact Lens Care Products With Contact Lenses In A Lens Case, Challenged With Bacterial And Fungal Organisms
10-103 ANSI Z80.18-2016
American National Standard For Ophthalmics - Contact Lens Care Products - Vocabulary, Performance Specifications, And Test Methodology
10-111 ISO 11981 Third Edition 2017-11
Ophthalmic Optics - Contact Lenses And Contact Lens Care Products - Determination Of Physical Compatibility Of Contact Lens Care Products With Contact Lenses
10-112 ISO 11986 Third Edition 2017-11
Ophthalmic Optics - Contact Lenses And Contact Lens Care Products - Determination Of Preservative Uptake And Release

Total Product Life Cycle

Device Type ID	4352
Device	Products, Contact Lens Care, Rigid Gas Permeable
Product Code	MRC
FDA Device Classification	Class 2 Medical Device
Regulation Description	Rigid Gas Permeable Contact Lens Care Products.
CFR Regulation Number	886.5918 [🔎]

Premarket Reviews
Manufacturer	Decision
BAUSCH & LOMB, INC.
	SUBSTANTIALLY EQUIVALENT	2
CONTAMAC LTD.
	SUBSTANTIALLY EQUIVALENT	1
MENICON CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Adverse Event Without Identified Device Or Use Problem	4
Device Operates Differently Than Expected	1
Total Device Problems	5

TPLC Last Update: 2019-04-02 20:47:28